[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100237851":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":10,"locations":32,"responsibleParty":72,"collaborators":74,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":10,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":10,"maxAge":96,"enrollmentInfo":97,"targetDuration":10,"studyType":100,"phases":10,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":113,"whyStopped":10,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Active surveillance 6-12 weeks",null,"Children were identified at the first administration of Diphtheria-tetanus-whole- cell pertussis-hepatitis B- Haemophilus influenza type b pentavalent (DTP\u002FHepB\u002FHib) vaccine (usually given at 6weeks of age) and home visits were conducted according to DTP\u002FHepB\u002FHib vaccine schedule.",[13],"Procedure: Blood collection",{"label":15,"type":10,"description":16,"interventionNames":17},"Active surveillance 5-17 months","Children who were either identified at the first administration of the DTP\u002FHepB\u002FHib vaccine (usually given at 6 weeks of age), with home visits scheduled from 5 months of age onwards or identified at first encounter with the study staff, with home visits started within one week of the first encounter with study staff.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Enhanced hospitalization surveillance","All children under the age of 5 years within the study areas, who were not already enrolled in active surveillance were eligible for enrolment in enhanced hospitalization surveillance during any hospitalizations throughout the entire study period.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"PROCEDURE","Blood collection","For all hospitalised children suspected of having an AESI or meningitis, a sample of 5 ml of whole blood was collected and the serum was stored.",[15,9,19],[29],{"name":30,"affiliation":5,"role":31},"GSK Clinical Trials","STUDY_DIRECTOR",[33,44,46,55,62],{"facility":34,"status":10,"city":35,"state":10,"zip":10,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":10},"GSK Investigational Site","Ouagadougou","Burkina Faso","BF",{"type":39,"coordinates":40},"Point",[41,42],-1.53388,12.36566,{"lat":42,"lon":41},{"facility":34,"status":10,"city":45,"state":10,"zip":10,"country":36,"countryCode":37,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"PO BOX 02 Nouna",{"facility":34,"status":10,"city":47,"state":10,"zip":10,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":54,"contacts":10},"Kintampo","Ghana","GH",{"type":39,"coordinates":51},[52,53],-1.73058,8.05627,{"lat":53,"lon":52},{"facility":34,"status":10,"city":56,"state":10,"zip":10,"country":48,"countryCode":49,"cosmosGeoPoint":57,"geoPoint":61,"contacts":10},"Navrongo",{"type":39,"coordinates":58},[59,60],-1.09083,10.89469,{"lat":60,"lon":59},{"facility":34,"status":10,"city":63,"state":10,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":71,"contacts":10},"Kisumu","40102","Kenya","KE",{"type":39,"coordinates":68},[69,70],34.76171,-0.10221,{"lat":70,"lon":69},{"type":73,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[75,78,80,82,84,86],{"name":76,"class":77},"PATH","OTHER",{"name":79,"class":77},"Agence de Médecine Préventive, France",{"name":81,"class":77},"Réseau en Afrique Francophone pour la Télémédecine,",{"name":83,"class":6},"IQVIA Pty Ltd",{"name":85,"class":6},"Parexel",{"name":87,"class":77},"Clinical Laboratory Services","100237851","a-surveillance-study-of-diseases-specified-as-adverse-events-of-special-interest-of-other-adverse-events-leading-to-hospitalisation-or-death-and-of-meningitis-in-children-in-africa-prior-to-implementation-of-the-rtssas01e-candidate-vaccine-100237851",true,"NCT02374450","A Surveillance Study of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Children in Africa Prior to Implementation of the RTS,S\u002FAS01E Candidate Vaccine","A Prospective Study to Estimate the Incidence of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Infants and Young Children in Sub-Saharan Africa Prior to Implementation of the RTS,S\u002FAS01E Candidate Vaccine","Inclusion Criteria:\n\nAll subjects must satisfy ALL the following criteria at study entry:\n\n* Subjects' parent(s)\u002FLegally Acceptable Representative(s) \\[LAR(s)\\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* Written informed consent provided from either the parent(s) or LAR of the subject.\n* Subject living in the Health and Demographic Surveillance System (HDSS) area.\n* For enrolment in active surveillance: children must be \\\u003C18 months of age. OR\n* For enrolment in enhanced hospitalisation surveillance: children must be \\\u003C5 years of age and hospitalised at any time during the study.\n\nExclusion Criteria:\n\n* Child in care.","ALL","5 Years",{"count":98,"type":99},36366,"ACTUAL","OBSERVATIONAL","The purpose of this pre-licensure cohort study was to estimate the incidence of adverse events of special interest (AESI), other adverse events (AE) leading to hospitalisation or death, meningitis and malaria in sub-Saharan African children under 5 years of age. The outcomes of this study provide the baseline data for the post-licensure EPI-MALARIA-003 (115056) study that evaluated the safety, effectiveness and impact of the RTS,S\u002FAS01E vaccine.\n\nAn interim analysis was performed on a sub-group of study participants enrolled in active surveillance from sites where the vaccine was implemented, having 6 months of follow-up after the administration of dose 3 of DTP\u002FHepB\u002FHib vaccine (6-12 weeks group), or 6 months after Visit 3 (mimicking the RTS,S\u002FAS01E primary vaccination schedule) for the 5-17 months group; corresponding to Visit 5. The interim analysis concerned primary safety endpoints and the main secondary endpoints.",[103],"Malaria",[103,105,106,107,108,109,110,111,112],"Surveillance study","Adverse Events of Specific Interest (AESI)","Children","Infants","Adverse events (AE) leading to hospitalisation or death","Meningitis","Epidemiology","Africa","COMPLETED","2024-09-13",{"date":116,"type":99},"2024-09-19",{"date":118,"type":99},"2015-10-05",{"date":120,"type":99},"2022-08-02",{"name":5,"class":6},5]